Standard No.:	GB/T 46943-2025
English Name:	Clinical laboratory testing and in vitro diagnostic test systems—General requirements for metagenomic next-generation sequencing validation
Chinese Name:	临床实验室检测和体外诊断系统 病原宏基因组高通量测序性能确认通用要求
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	GB    National Standard
ICS Classification:	11.100.10 11.100.10    In vitro diagnostic test systems 11.100.10
Source Content Issued by:	SAMR;SAC
Issued on:	2025-12-31
Implemented on:	2027-1-1
Status:	to be valid
Target Language:	English
File Format:	PDF
Word Count:	10500 words
Translation Price(USD):	315.0
Delivery:	via email in 1~5 business day

本文件规定了临床检验实验室开展病原宏基因组高通量测序（metagenomic next-generation sequencing；mNGS）前，进行性能确认的相关要求。
本文件适用于临床检验实验室使用高通量测序技术开展mNGS的性能确认。
本文件不适用于采用生物纳米孔、固态纳米孔等为主要技术原理的单分子病原测序的性能确认，也不适用于采用靶向探针杂交捕获或多重引物扩增技术建立的病原测序的性能确认。